Impact of Starting Dose of Vasopressor on Hemodynamic Response in Shock

Not Applicable

Not yet recruiting

• Conditions: Shock
• Interventions: Other: Starting dose of NE

• Registration Number: NCT06481839
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

This study is designed to assess the effect of initial vasopressor dose on clinical outcomes. To date, there are no clinical guidelines or recommendations regarding the dose of vasopressor medication that should be initiated before titrating to a mean arterial pressure (MAP) in patients with circulatory shock. High heterogeneity and clinical equipoise regarding this variable exist in routine clinical practice. However, there is strong evidence that delays in achieving MAP goals lead to worse clinical outcomes. The study will randomize patients with circulatory shock to a low (5mcg/min of norepinephrine) or high (15mcg/min of norepinephrine) initial starting dose followed by the usual protocolized titration to MAP goal. The time to reach the goal MAP, organ dysfunction, hospital length of stay, and mortality will be measured for each group.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-01
• Study Start: 2024-07-24
• Primary Completion: 2026-07-24
• Study Completion: 2028-07-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients at least 18 years old
• Patients who are diagnosed with shock (MAP < 65 mmHg) require the initiation of vasopressors
• Care provided in the ED or admission to the Medical Intensive Care Unit (MICU)
• Norepinephrine chosen as first-line vasopressor by the treating clinician

Exclusion Criteria

• Patients who are receiving vasopressors or inotropes prior to UI Health hospital presentation/admission
• Baseline MAP >/= 65 mmHg
• Pregnant patients (checked as standard of care on admission)
• Prisoners.
• Immediate post-cardiac arrest patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Low-dose NE	Starting dose of NE	-
High-dose NE	Starting dose of NE	-

Primary Outcome Measures

Name	Time	Method
Mean arterial blood pressure	During first shock episode, up to 28 days of shock episode.	Time to achieve and sustain a mean arterial pressor greater than or equal to 65 mmHg